NCT00309751已完成3 期
Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Kowa Research Europe35 个研究点 分布在 6 个国家目标入组 418 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 试验地点
- 35
- 主要终点
- Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females (ages 18-75 years)
- •Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
- •Must have been following a restrictive diet
- •Diagnosis of combined dyslipidemia
排除标准
- •Homozygous familial hypercholesterolemia
- •Conditions which may cause secondary dyslipidemia
- •Uncontrolled diabetes mellitus
- •Abnormal pancreatic, liver, or renal function
- •Abnormal serum creatine kinase (CK) above the pre-specified level
- •Significant heart disease
研究组 & 干预措施
Pitavastatin 4 mg QD
Experimental
Pitavastatin 4 mg once daily
干预措施: Pitavastatin (Drug)
Atorvastatin 20 mg QD
Active Comparator
Atorvastatin 20 mg once daily
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
时间窗: 12 weeks
Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)
次要结局
- Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target(12 weeks)
研究者
研究点 (35)
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